FDA-Cleared BrainScope One Provides Proprietary, Objective EEG-Based Biomarker for Brain Injury, Including Concussion
BETHESDA, MD. June 14, 2017 – BrainScope Company, Inc. today announced a publication describing that its EEG-based Brain Function Index (BFI) was demonstrated to have a significant relationship with the severity of functional impairment in mild head injured patients in a large (720 patient) multisite independent validation trial. BrainScope includes the BFI as a core component of its recently FDA-cleared BrainScope One product, which provides EEG and other information presented as a comprehensive panel on a handheld device for assessment of the full spectrum of traumatic brain injury.
Published online in the peer-reviewed Journal of Neurotrauma in an article entitled “A brain electrical activity (EEG) based biomarker of functional impairment in traumatic head injury: a multisite validation trial”, the findings support the BFI as a quantitative biomarker of brain function impairment, which scaled with severity of impairment in mild brain injury patients.